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This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| daxibotulinumtoxinA (DAXI) for injection | Experimental | DAXI for injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DaxibotulinumtoxinA | Biological | Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of dystonia as measured by change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total Score | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS) - Total Score | Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24 | |
| Change from baseline in TWSTRS subscale scores (Severity, Disability and Pain) | Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nubia Kaba | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parkinson's & Movement Disorder Institute | Fountain Valley | California | 92708 | United States | ||
| Colorado Springs Neurological Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30009213 | Derived | Jankovic J, Truong D, Patel AT, Brashear A, Evatt M, Rubio RG, Oh CK, Snyder D, Shears G, Comella C. Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose-Escalation Multicenter Study. Mov Disord Clin Pract. 2018 Apr 26;5(3):273-282. doi: 10.1002/mdc3.12613. eCollection 2018 May-Jun. |
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| Duration of effect based on number of weeks from treatment until return of symptoms that warrant treatment | Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24 |
| Percentage of treatment responders with at least a 20% reduction in the TWSTRS - Total score post-treatment | Weeks 2, 4, 6, 9, 12, 16, 20, 24 |
| Patient-rated quality of life measurement based upon change from baseline of the Cervical Dystonia Impact Profile Scale (CDIP-58) | Post-treatment: Weeks 4, 6, 12, 16, 20, 24 |
| Percentage of responders showing improvement on Clinical Global Impression of Change (CGIC) | Post-treatment: Weeks 2, 4, 6, 9, 12, 16, 20, 24 |
| Colorado Springs |
| Colorado |
| 80907 |
| United States |
| University of Florida Center for Movement Disorders & Neurorestoration | Gainesville | Florida | 32607 | United States |
| Precision Research Organization | Miami Lakes | Florida | 33016 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Kansas City Bone & Joint Clinic | Overland Park | Kansas | 66211 | United States |
| The NeuroMedical Center Clinic | Baton Rouge | Louisiana | 70810 | United States |
| Wake forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| Riverhills Healthcare, Inc. | Cincinnati | Ohio | 45212 | United States |
| Coastal Neurology | Port Royal | South Carolina | 29935 | United States |
| Parkinson's Disease Center and Movement Disorder Clinic | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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